NCT04334291

Brief Summary

The investigators propose to select all COVID 19 patients attended in any health center (with in hospital beds), who have been discharged or have died at the time of the evaluation. The main objective of the present study is to carefully characterize the clinical profile of patients infected with COVID-19 in order to develop a simple prognostic clinical score allowing, in selected cases, rapid logistic decision making (discharge with follow-up, referral to provisional/field hospitals or admission to more complex hospital centers). As secondary objectives, the analysis of the risk-adjusted influence of treatments and previous comorbidities of patients infected with the disease will be performed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,168

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 1, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2020

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2022

Enrollment Period

1 month

First QC Date

April 1, 2020

Last Update Submit

January 9, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Death

    All cause

    through study completion, an average of 1 month

Secondary Outcomes (10)

  • In hospital stay.

    through study completion, an average of 1 month

  • Heart failure

    through study completion, an average of 1 month

  • Renal failure

    through study completion, an average of 1 month

  • Respiratory Insufficiency.

    through study completion, an average of 1 month

  • Upper respiratory tract involvement

    through study completion, an average of 1 month

  • +5 more secondary outcomes

Interventions

Observational (registry)COMBINATION_PRODUCT

Observational study.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Confirmed diagnosis or a COVID-19 high suspicion.

You may qualify if:

  • Patients discharged (deceased or alive) from any hospital center with a confirmed diagnosis or a COVID-19 high suspicion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Lclinico San Carlos

Madrid, 28040, Spain

Location

Related Publications (25)

  • Nunez-Gil IJ, Estrada V, Fernandez-Perez C, Feltes G, Vedia O, Vergara-Uzcategui CE, Moreno-Menguia VH, Cerrato E, D'Ascenzo F, Raposeiras-Roubin S, Martin-Sanchez FJ, Alfonso-Rodriguez E, Huang J, Ramakrishna H, Gil-Higes E, Fernandez-Ortiz A, Macaya C. Health Outcome Predictive Evaluation for COVID 19 international registry (HOPE COVID-19), rationale and design. Contemp Clin Trials Commun. 2020 Dec;20:100654. doi: 10.1016/j.conctc.2020.100654. Epub 2020 Sep 23.

    PMID: 32989425BACKGROUND
  • Uribarri A, Nunez-Gil IJ, Aparisi A, Arroyo-Espliguero R, Maroun Eid C, Romero R, Becerra-Munoz VM, Feltes G, Molina M, Garcia-Aguado M, Cerrato E, Capel-Astrua T, Alfonso-Rodriguez E, Castro-Mejia AF, Raposeiras-Roubin S, Espejo C, Perez-Sole N, Bardaji A, Marin F, Fabregat-Andres O, D'ascenzo F, Santoro F, Akin I, Estrada V, Fernandez-Ortiz A, Macaya C; HOPE COVID-19 investigators. Atrial fibrillation in patients with COVID-19. Usefulness of the CHA2DS2-VASc score: an analysis of the international HOPE COVID-19 registry. Rev Esp Cardiol (Engl Ed). 2021 Jul;74(7):608-615. doi: 10.1016/j.rec.2020.12.009. Epub 2021 Jan 13.

    PMID: 33583755BACKGROUND
  • Pepe M, Maroun-Eid C, Romero R, Arroyo-Espliguero R, Fernandez-Rozas I, Aparisi A, Becerra-Munoz VM, Garcia Aguado M, Brindicci G, Huang J, Alfonso-Rodriguez E, Castro-Mejia AF, Favretto S, Cerrato E, Albiol P, Raposeiras-Roubin S, Vedia O, Feltes Guzman G, Carrero-Fernandez A, Perez Cimarra C, Buzon L, Jativa Mendez JL, Abumayyaleh M, Corbi-Pascual M, Macaya C, Estrada V, Nestola PL, Biondi-Zoccai G, Nunez-Gil IJ. Clinical presentation, therapeutic approach, and outcome of young patients admitted for COVID-19, with respect to the elderly counterpart. Clin Exp Med. 2021 May;21(2):249-268. doi: 10.1007/s10238-021-00684-1. Epub 2021 Feb 8.

    PMID: 33555436BACKGROUND
  • Rivera-Caravaca JM, Nunez-Gil IJ, Vivas D, Viana-Llamas MC, Uribarri A, Becerra-Munoz VM, Trabattoni D, Fernandez Rozas I, Feltes G, Lopez-Pais J, El-Battrawy I, Macaya C, Fernandez-Ortiz A, Estrada V, Marin F; HOPE COVID-19 Investigators. Clinical profile and prognosis in patients on oral anticoagulation before admission for COVID-19. Eur J Clin Invest. 2021 Jan;51(1):e13436. doi: 10.1111/eci.13436. Epub 2020 Nov 7.

  • Nunez-Gil IJ, Fernandez-Perez C, Estrada V, Becerra-Munoz VM, El-Battrawy I, Uribarri A, Fernandez-Rozas I, Feltes G, Viana-Llamas MC, Trabattoni D, Lopez-Pais J, Pepe M, Romero R, Castro-Mejia AF, Cerrato E, Astrua TC, D'Ascenzo F, Fabregat-Andres O, Moreu J, Guerra F, Signes-Costa J, Marin F, Buosenso D, Bardaji A, Raposeiras-Roubin S, Elola J, Molino A, Gomez-Doblas JJ, Abumayyaleh M, Aparisi A, Molina M, Guerri A, Arroyo-Espliguero R, Assanelli E, Mapelli M, Garcia-Acuna JM, Brindicci G, Manzone E, Ortega-Armas ME, Bianco M, Trung CP, Nunez MJ, Castellanos-Lluch C, Garcia-Vazquez E, Cabello-Clotet N, Jamhour-Chelh K, Tellez MJ, Fernandez-Ortiz A, Macaya C; HOPE COVID-19 Investigators. Mortality risk assessment in Spain and Italy, insights of the HOPE COVID-19 registry. Intern Emerg Med. 2021 Jun;16(4):957-966. doi: 10.1007/s11739-020-02543-5. Epub 2020 Nov 9.

  • Nunez-Gil IJ, Estrada V, Fernandez-Perez C, Fernandez-Rozas I, Martin-Sanchez FJ, Macaya C. The COVID-19 curve, health system overload, and mortality. Emergencias. 2020 Ago;32(4):293-295. No abstract available. English, Spanish.

  • Uribarri A, Nunez-Gil IJ, Aparisi A, Becerra-Munoz VM, Feltes G, Trabattoni D, Fernandez-Rozas I, Viana-Llamas MC, Pepe M, Cerrato E, Capel-Astrua T, Romero R, Castro-Mejia AF, El-Battrawy I, Lopez-Pais J, D'Ascenzo F, Fabregat-Andres O, Bardaji A, Raposeiras-Roubin S, Marin F, Fernandez-Ortiz A, Macaya C, Estrada V; HOPE COVID-19 Investigators. Impact of renal function on admission in COVID-19 patients: an analysis of the international HOPE COVID-19 (Health Outcome Predictive Evaluation for COVID 19) Registry. J Nephrol. 2020 Aug;33(4):737-745. doi: 10.1007/s40620-020-00790-5. Epub 2020 Jun 29.

  • Nunez-Gil IJ, Fernandez-Ortiz A, Maroud Eid C, Huang J, Romero R, Becerra-Munoz VM, Uribarri A, Feltes G, Trabatoni D, Fernandez-Rozas I, Viana-Llamas MC, Pepe M, Cerrato E, Bertaina M, Capel Astrua T, Alfonso E, Castro-Mejia AF, Raposeiras-Roubin S, D'Ascenzo F, Espejo Paeres C, Signes-Costa J, Bardaji A, Fernandez-Perez C, Marin F, Fabregat-Andres O, Akin I, Estrada V, Macaya C. Underlying heart diseases and acute COVID-19 outcomes. Cardiol J. 2021;28(2):202-214. doi: 10.5603/CJ.a2020.0183. Epub 2020 Dec 21.

  • Becerra-Munoz VM, Nunez-Gil IJ, Eid CM, Garcia Aguado M, Romero R, Huang J, Mulet A, Ugo F, Rametta F, Liebetrau C, Aparisi A, Fernandez-Rozas I, Viana-Llamas MC, Feltes G, Pepe M, Moreno-Rondon LA, Cerrato E, Raposeiras-Roubin S, Alfonso E, Carrero-Fernandez A, Buzon-Martin L, Abumayyaleh M, Gonzalez A, Fernandez Ortiz A, Macaya C, Estrada V, Fernandez-Perez C, Gomez-Doblas JJ. Clinical profile and predictors of in-hospital mortality among older patients hospitalised for COVID-19. Age Ageing. 2021 Feb 26;50(2):326-334. doi: 10.1093/ageing/afaa258.

  • Ruiz-Sanchez JG, Nunez-Gil IJ, Cuesta M, Rubio MA, Maroun-Eid C, Arroyo-Espliguero R, Romero R, Becerra-Munoz VM, Uribarri A, Feltes G, Trabattoni D, Molina M, Garcia Aguado M, Pepe M, Cerrato E, Alfonso E, Castro Mejia AF, Roubin SR, Buzon L, Bondia E, Marin F, Lopez Pais J, Abumayyaleh M, D'Ascenzo F, Rondano E, Huang J, Fernandez-Perez C, Macaya C, de Miguel Novoa P, Calle-Pascual AL, Estrada Perez V, Runkle I; HOPE COVID-19 investigators. Prognostic Impact of Hyponatremia and Hypernatremia in COVID-19 Pneumonia. A HOPE-COVID-19 (Health Outcome Predictive Evaluation for COVID-19) Registry Analysis. Front Endocrinol (Lausanne). 2020 Nov 30;11:599255. doi: 10.3389/fendo.2020.599255. eCollection 2020.

  • El-Battrawy I, Nunez-Gil IJ, Abumayyaleh M, Estrada V, Manuel Becerra-Munoz V, Uribarri A, Fernandez-Rozas I, Feltes G, Arroyo-Espliguero R, Trabattoni D, Lopez-Pais J, Pepe M, Romero R, Castro-Mejia AF, Cerrato E, Capel Astrua T, D'Ascenzo F, Fabregat-Andres O, Signes-Costa J, Marin F, Buonsenso D, Bardaji A, Jesus Tellez M, Fernandez-Ortiz A, Macaya C, Akin I. COVID-19 and the impact of arterial hypertension-An analysis of the international HOPE COVID-19 Registry (Italy-Spain-Germany). Eur J Clin Invest. 2021 Nov;51(11):e13582. doi: 10.1111/eci.13582. Epub 2021 Aug 19.

  • Signes-Costa J, Nunez-Gil IJ, Soriano JB, Arroyo-Espliguero R, Eid CM, Romero R, Uribarri A, Fernandez-Rozas I, Aguado MG, Becerra-Munoz VM, Huang J, Pepe M, Cerrato E, Raposeiras S, Gonzalez A, Franco-Leon F, Wang L, Alfonso E, Ugo F, Garcia-Prieto JF, Feltes G, Abumayyaleh M, Espejo-Paeres C, Jativa J, Masjuan AL, Macaya C, Carbonell Asins JA, Estrada V; HOPE COVID-19 investigators. Prevalence and 30-Day Mortality in Hospitalized Patients With Covid-19 and Prior Lung Diseases. Arch Bronconeumol. 2021 Apr;57:13-20. doi: 10.1016/j.arbres.2020.11.012. Epub 2020 Dec 16.

  • Santoro F, Nunez-Gil IJ, Vitale E, Viana-Llamas MC, Reche-Martinez B, Romero-Pareja R, Feltez Guzman G, Fernandez Rozas I, Uribarri A, Becerra-Munoz VM, Alfonso-Rodriguez E, Garcia-Aguado M, Huang J, Ortega-Armas ME, Garcia Prieto JF, Corral Rubio EM, Ugo F, Bianco M, Mulet A, Raposeiras-Roubin S, Jativa Mendez JL, Espejo Paeres C, Albarran AR, Marin F, Guerra F, Akin I, Cortese B, Ramakrishna H, Macaya C, Fernandez-Ortiz A, Brunetti ND. Antiplatelet therapy and outcome in COVID-19: the Health Outcome Predictive Evaluation Registry. Heart. 2022 Jan;108(2):130-136. doi: 10.1136/heartjnl-2021-319552. Epub 2021 Oct 5.

  • Nunez-Gil IJ, Olier I, Feltes G, Viana-Llamas MC, Maroun-Eid C, Romero R, Fernandez-Rozas I, Uribarri A, Becerra-Munoz VM, Alfonso-Rodriguez E, Garcia-Aguado M, Elola J, Castro-Mejia A, Pepe M, Garcia-Prieto JF, Gonzalez A, Ugo F, Cerrato E, Bondia E, Raposeiras-Roubin S, Mendez JLJ, Espejo C, Lopez-Masjuan A, Marin F, Lopez-Pais J, Abumayyaleh M, Corbi-Pascual M, Liebetrau C, Ramakrishna H, Estrada V, Macaya C, Fernandez-Ortiz A; HOPE COVID-19 Investigators (Cols Appendix). Renin-angiotensin system inhibitors effect before and during hospitalization in COVID-19 outcomes: Final analysis of the international HOPE COVID-19 (Health Outcome Predictive Evaluation for COVID-19) registry. Am Heart J. 2021 Jul;237:104-115. doi: 10.1016/j.ahj.2021.04.001. Epub 2021 Apr 15.

  • Porta-Etessam J, Nunez-Gil IJ, Gonzalez Garcia N, Fernandez-Perez C, Viana-Llamas MC, Eid CM, Romero R, Molina M, Uribarri A, Becerra-Munoz VM, Aguado MG, Huang J, Rondano E, Cerrato E, Alfonso E, Mejia AFC, Marin F, Roubin SR, Pepe M, Feltes G, Mate P, Cortese B, Buzon L, Mendez JJ, Estrada V. COVID-19 anosmia and gustatory symptoms as a prognosis factor: a subanalysis of the HOPE COVID-19 (Health Outcome Predictive Evaluation for COVID-19) registry. Infection. 2021 Aug;49(4):677-684. doi: 10.1007/s15010-021-01587-9. Epub 2021 Mar 1.

  • Espejo-Paeres C, Nunez-Gil IJ, Estrada V, Fernandez-Perez C, Uribe-Heredia G, Cabre-Verdiell C, Uribarri A, Romero R, Garcia-Aguado M, Fernandez-Rozas I, Becerra-Munoz V, Pepe M, Cerrato E, Raposeiras-Roubin S, Barrionuevo-Ramos M, Aveiga-Ligua F, Aguilar-Andrea C, Alfonso-Rodriguez E, Ugo F, Garcia-Prieto JF, Feltes G, Akin I, Huang J, Jativa J, Fernandez-Ortiz A, Macaya C, Carrero-Fernandez A, Signes-Costa J. Impact of smoking on COVID-19 outcomes: a HOPE Registry subanalysis. BMJ Nutr Prev Health. 2021 Jun 17;4(1):285-292. doi: 10.1136/bmjnph-2021-000269. eCollection 2021.

  • Viana-Llamas MC, Arroyo-Espliguero R, Silva-Obregon JA, Uribe-Heredia G, Nunez-Gil I, Garcia-Magallon B, Toran-Martinez CG, Castillo-Sandoval A, Diaz-Caraballo E, Rodriguez-Guinea I, Dominguez-Lopez J. Hypoalbuminemia on admission in COVID-19 infection: An early predictor of mortality and adverse events. A retrospective observational study. Med Clin (Barc). 2021 May 7;156(9):428-436. doi: 10.1016/j.medcli.2020.12.018. Epub 2021 Jan 28.

  • Abumayyaleh M, Nunez Gil IJ, El-Battrawy I, Estrada V, Becerra-Munoz VM, Aparisi A, Fernandez-Rozas I, Feltes G, Arroyo-Espliguero R, Trabattoni D, Lopez-Pais J, Pepe M, Romero R, Garcia DRV, Biole C, Astrua TC, Eid CM, Alfonso E, Fernandez-Presa L, Espejo C, Buonsenso D, Raposeiras S, Fernandez C, Macaya C, Akin I; HOPE COVID-19 investigators. Does there exist an obesity paradox in COVID-19? Insights of the international HOPE-COVID-19-registry. Obes Res Clin Pract. 2021 May-Jun;15(3):275-280. doi: 10.1016/j.orcp.2021.02.008. Epub 2021 Mar 3.

  • Abumayyaleh M, Nunez-Gil IJ, El-Battrawy I, Estrada V, Becerra-Munoz VM, Uribarri A, Fernandez-Rozas I, Feltes G, Arroyo-Espliguero R, Trabattoni D, Lopez Pais J, Pepe M, Romero R, Ortega-Armas ME, Bianco M, Astrua TC, D'Ascenzo F, Fabregat-Andres O, Ballester A, Marin F, Buonsenso D, Sanchez-Gimenez R, Weiss C, Fernandez Perez C, Fernandez-Ortiz A, Macaya C, Akin I. Sepsis of Patients Infected by SARS-CoV-2: Real-World Experience From the International HOPE-COVID-19-Registry and Validation of HOPE Sepsis Score. Front Med (Lausanne). 2021 Oct 14;8:728102. doi: 10.3389/fmed.2021.728102. eCollection 2021.

  • Perez-Segura P, Paz-Cabezas M, Nunez-Gil IJ, Arroyo-Espliguero R, Maroun Eid C, Romero R, Fernandez Rozas I, Uribarri A, Becerra-Munoz VM, Garcia Aguado M, Huang J, Rondano E, Cerrato E, Rodriguez EA, Ortega-Armas ME, Raposeiras Roubin S, Pepe M, Feltes G, Gonzalez A, Cortese B, Buzon L, El-Battrawy I, Estrada V. Prognostic factors at admission on patients with cancer and COVID-19: Analysis of HOPE registry data. Med Clin (Barc). 2021 Oct 8;157(7):318-324. doi: 10.1016/j.medcli.2021.02.021. Epub 2021 May 6.

  • Salgado-Aranda R, Perez-Castellano N, Nunez-Gil I, Orozco AJ, Torres-Esquivel N, Flores-Soler J, Chamaisse-Akari A, Mclnerney A, Vergara-Uzcategui C, Wang L, Gonzalez-Ferrer JJ, Filgueiras-Rama D, Canadas-Godoy V, Macaya-Miguel C, Perez-Villacastin J. Influence of Baseline Physical Activity as a Modifying Factor on COVID-19 Mortality: A Single-Center, Retrospective Study. Infect Dis Ther. 2021 Jun;10(2):801-814. doi: 10.1007/s40121-021-00418-6. Epub 2021 Mar 14.

  • Bertaina M, Nunez-Gil IJ, Franchin L, Fernandez Rozas I, Arroyo-Espliguero R, Viana-Llamas MC, Romero R, Maroun Eid C, Uribarri A, Becerra-Munoz VM, Huang J, Alfonso E, Marmol-Mosquera F, Ugo F, Cerrato E, Fernandez-Presa L, Raposeiras Roubin S, Feltes Guzman G, Gonzalez A, Abumayyaleh M, Fernandez-Ortiz A, Macaya C, Estrada V; HOPE COVID-19 investigators. Non-invasive ventilation for SARS-CoV-2 acute respiratory failure: a subanalysis from the HOPE COVID-19 registry. Emerg Med J. 2021 May;38(5):359-365. doi: 10.1136/emermed-2020-210411. Epub 2021 Mar 16.

  • Rivera-Caravaca JM, Nunez-Gil IJ, Lip GYH, Uribarri A, Viana-Llamas MC, Gonzalez A, Castro-Mejia AF, Alonso Gonzalez B, Alfonso E, Garcia Prieto JF, Cavallino C, Cortese B, Feltes G, Fernandez-Rozas I, Signes-Costa J, Huang J, Garcia Aguado M, Pepe M, Romero R, Cerrato E, Becerra-Munoz VM, Raposeiras Roubin S, Santoro F, Bagur R, Sposato L, El-Battrawy I, Lopez Masjuan A, Fernandez-Ortiz A, Estrada V, Macaya C, Marin F. Chronic Oral Anticoagulation Therapy and Prognosis of Patients Admitted to Hospital for COVID-19: Insights from the HOPE COVID-19 Registry. Int J Clin Pract. 2022 May 26;2022:7325060. doi: 10.1155/2022/7325060. eCollection 2022.

  • El-Battrawy I, Longo F, Nunez Gil IJ, Abumayyaleh M, Gianesin B, Estrada V, Aparisi A, Arroyo-Espliguero R, Balocco M, Barella S, Beccaria A, Bonetti F, Casale M, De Michele E, Denotti AR, Fidone C, Fortini M, Gamberini MR, Graziadei G, Lisi R, Massa A, Marcon A, Rubinski B, Miano M, Motta I, Pinto VM, Piperno A, Mariani R, Putti MC, Quota A, Ribersani M, Marziali M, Roberti D, Rosso R, Tartaglione I, Vitucci A, Voi V, Zecca M, Romero R, Marouneld C, Fernandez-Rozas I, Espejo C, Marhaeni W, Garcia Aguado M, Cappellini MD, Perrotta S, De Franceschi L, Piga A, Forni GL, Akin I. Thalassaemia is paradoxically associated with a reduced risk of in-hospital complications and mortality in COVID-19: Data from an international registry. J Cell Mol Med. 2022 May;26(9):2520-2528. doi: 10.1111/jcmm.17026. Epub 2022 Mar 30.

  • Biole C, Bianco M, Nunez-Gil IJ, Cerrato E, Spirito A, Roubin SR, Viana-Llamas MC, Gonzalez A, Castro-Mejia AF, Eid CM, Fernandez-Perez C, Uribarri A, Alfonso-Rodriguez E, Ugo F, Guerra F, Feltes G, Akin I, Fernandez-Rozas I, Blasco-Angulo N, Huang J, Aguado MG, Pepe M, Romero R, Becerra-Munoz VM, Estrada V, Macaya C. Gender Differences in the Presentation and Outcomes of Hospitalized Patients With COVID-19. J Hosp Med. 2021 Jun;16(6):349-352. doi: 10.12788/jhm.3594.

MeSH Terms

Conditions

COVID-19

Interventions

Registries

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesRecordsOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator. Attending Physician. MD, PhD, FESC

Study Record Dates

First Submitted

April 1, 2020

First Posted

April 6, 2020

Study Start

March 23, 2020

Primary Completion

May 1, 2020

Study Completion

May 31, 2020

Last Updated

January 25, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

IPD are to be share among HOPE researchers. However, the HOPE Steering committee is open to collaborative proposals.

Locations